Guidewire and catheter locking device and method

ABSTRACT

Locking device that is mounted on an endoscope or the like for selectively securing the position of a guide wire and/or catheter relative to the endoscope or the like. The locking device preferably includes a side wall with an opening therein for receiving the proximal end of a guide wire or catheter. The opening is preferably J-shaped or boot shaped, and has an entry end and a locking end. Once a guide wire or catheter is in a desired position within a body cavity, the portion of the guide wire or catheter that extends outside of the endoscope or the like may be moved into the opening. More particularly, a portion of the guide wire or catheter may be inserted by an operator through the entry end of the opening and into the locking end, wherein the locking end frictionally secures the position of the guide wire or catheter relative to the endoscope or the like.

RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 10/723,053, filed Nov. 26, 2003; which is a continuation ofU.S. patent application Ser. No. 09/512,997, filed Feb. 25, 2000, nowU.S. Pat. No. 6,663,597; which is a continuation of U.S. patentapplication Ser. No. 09/080,520, filed May 18, 1998, now U.S. Pat. No.6,096,009; which is a continuation-in-part of U.S. patent applicationSer. No. 08/926,200, filed on Sep. 9, 1997, entitled “Single OperatorExchange Biliary Catheter”, now U.S. Pat. No. 6,007,522; which claimsthe benefit of priority under 35 U.S.C. §119(e) to provisionalapplication U.S. Ser. No. 60/025,235, filed Sep. 13, 1996, entitled“Single Operator, Exchange Biliary Catheter”, the entire disclosures ofwhich are all incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a guide wire and/or a catheter lockingdevice for use in catheter procedures within the human anatomy, andmethods of using the same. The locking device is particularly usefulduring catheter exchange procedures. The present invention includes alocking device that is attached to an endoscope, a guide catheter, orother guiding type catheter that receives a guide wire and/or anothercatheter. The locking device is used to selectively secure the guidewire and/or catheter in a desired position within the endoscope orguiding type catheter. This may reduce the likelihood that the guidewire and/or catheter will move from a desired placement during aprocedure, such as a catheter exchange procedure.

DESCRIPTION OF THE PRIOR ART

Endoscopic procedures for treating abnormal pathologies within thealimentary canal system and biliary tree (including the biliary,hepatic, and pancreatic ducts) are increasing in number. The endoscopeprovides access to the general area of a desired duct using directvisualization. However, the duct itself must be navigated using acatheter in conjunction with fluoroscopy and guide wires.

Catheters are known for treatment of targeted anatomical regions. Knownmethods and devices for using biliary catheters for accessing thebiliary tree for performing catheter procedures are disclosed in Weaveret al., U.S. Pat. No. 5,397,302 and Karpiel, U.S. Pat. No. 5,320,602,the disclosures of which are herein incorporated by reference. Ingeneral, for treatment of an abnormal pathology within a patient'sbiliary tree, an endoscope is first introduced into the mouth of thepatient. The endoscope includes a proximal end and a distal end, and hasa lumen extending longitudinally between the proximal and distal ends.The endoscope is guided through the patient's alimentary tract or canaluntil an opening at the distal end of the endoscope is proximate thearea to receive treatment. At this point, the endoscope allows othercomponents, such as a catheter, to access the targeted area.

For visualization or treatment within the biliary tree, the distal endof the endoscope is positioned proximate the papilla of vater leading tothe common bile duct and the pancreatic duct. A catheter is guidedthrough the lumen of the endoscope until a distal tip of the catheteremerges from the opening at the distal end of the endoscope.

The catheter may be used for accessing the biliary tree. The distal endof the catheter is guided through the orifice to the papilla of vater(located between the sphincter of oddi) leading to the common bile ductand the pancreatic duct. A guide wire may be used in conjunction withthe catheter to facilitate accessing a desired location within thebiliary tree. The guide wire is inserted in an opening at a proximal endof the catheter and guided through the catheter until it emerges fromthe distal end of the catheter.

If visualization of the common bile duct is desired, the guide wire isguided into the common bile duct. The catheter is advanced over theguide wire, as previously described, until the distal end of thecatheter is positioned in the common bile duct at the desired location.The catheter is now in position for delivery of contrast media forfluoroscopic visualization of anatomical detail within the common bileduct. Visualization may reveal selected areas within the common bileduct that require treatment. To treat the selected areas, a differentcatheter is typically required, necessitating a catheter exchange. Acatheter exchange typically involves removing the first catheter fromthe endoscope over the guide wire, and advancing a second catheter overthe guide wire to the desired treatment site. Thus, once the guide wireis in place relative to the targeted area, it is highly desirable tomaintain the position of the guide wire during subsequent catheterprocedures, including during a catheter exchange procedure. If the guidewire moves during such a procedure, the guide wire may have to bere-directed through the body ducts to the target site, which is often adifficult, time consuming and tedious task.

In addition to performing a catheter exchange procedure, it may also bedesirable to perform a guide wire exchange procedure. This may bedesirable when, for example, a first guide wire is too large to fitthrough a desired body duct, or otherwise lacks the desiredcharacteristics. Under these circumstances, a physician may leave thecatheter in place, withdraw the first guide wire from the catheter, andinsert a second guide wire through the catheter to the desired site.During this procedure, the catheter guides the guide wire to the desiredsite. Thus, once the catheter is positioned at a target site, it ishighly desirable to maintain the position of the catheter during a guidewire exchange procedure so that the second guide wire may be guideddirectly to the desired site in a minimum amount of time.

To maintain the position of a guide wire and/or catheter, a physiciantypically must grasp the proximal end of the guide wire and/or catheterwith one hand, and performing the corresponding exchange with the other.This is difficult, and often results in the movement of the guide wireand/or catheter. Therefore, it would be desirable to provide a lockingdevice whereby the physician can secure the position of the guide wireand/or catheter during an exchange procedure, thereby freeing both handsto perform other tasks.

SUMMARY OF THE INVENTION

The present invention overcomes many of the disadvantages of the priorart by providing a locking device that is mounted on an endoscope or thelike for selectively securing the position of a guide wire and/orcatheter relative to the endoscope or the like. The locking devicepreferably includes a side wall with an opening therein for receivingthe guide wire or catheter near its proximal end or at any point alongthe guide wire or catheter's length depending upon how far it isinserted. The opening is preferably J-shaped or boot shaped, and has anentry slot and a locking slot. Once a guide wire or catheter is in adesired position within a body cavity, a portion of the guide wire orcatheter that extends outside of the endoscope or the like is alignedwith the opening and may be moved into the opening in use. Moreparticularly, a portion of the guide wire or catheter may be inserted byan operator through the entry slot of the opening and into the lockingslot, wherein the locking slot frictionally secures the position of theguide wire or catheter relative to the endoscope or the like.

In one illustrative embodiment, the locking device includes a bodymember that is funnel shaped including a horn and a neck with a lumenextending therethrough. The horn has a side wall with an openingprovided therein. The neck is operatively attached to the endoscope orthe like proximate an access port. In this configuration, a proximalportion of the guide wire or catheter extends out of the access port ofthe endoscope or the like and through the lumen of the locking device.Once a guide wire or catheter is in a desired position within a bodycavity, the proximal portion of the guide wire or catheter may be movedinto the opening in the body member of the locking device, andfrictionally fit therein.

In another illustrative embodiment, the locking device is adapted foruse with an endoscope having a side port. The side port is in fluidcommunication with one or more lumens, and may receive a guide wire orcatheter therein. In this embodiment, the locking device includes a bodymember, an attachment mechanism and a securing mechanism. The attachmentmechanism preferably includes one or more hook members that engage themain shaft of the endoscope near the side port. These hook members tendto clip or secure the locking device to the main shaft of the endoscope.The body member extends from the hook members generally parallel to theside port. The securing mechanism, which is preferably an opening in thebody member, is preferably positioned near the end of the body memberand proximate the side port opening of the endoscope. Once a guide wireor catheter is in a desired position within a body cavity, the proximalportion of the guide wire or catheter, which extends outside of the sideport of the endoscope, may be moved into the opening of the lockingdevice and frictionally fit therein. In preferred embodiments, theopening includes an entry slot and a locking slot, as described above.

It is contemplated that the locking device may include more than onesecuring mechanism for securing more than one guide wire or catheter orcombination of guide wires and catheters. This is preferablyaccomplished by including two or more openings in the body member of thelocking device. For example, one opening may be substantially J-shapedfor securing a guide wire. Another opening may be boot shaped forsecuring a catheter. The boot shape is similar to the J-shape but hasincreased dimensions for receiving the larger catheter shaft.

In use, a guide wire or catheter may be inserted into the lumen of anendoscope or the like. The locking device, which is preferablyoperatively attached to the shaft of the endoscope or the like, has awall with an opening therein. The opening is preferably positionedproximate an access port of the endoscope or the like. As describedabove, the opening preferably has a locking slot that has a reduceddimension relative to the outside portion of the guide wire or catheter.Once the guide wire or catheter is in a desired position within a bodycavity, the proximal portion of the guide wire or catheter isselectively secured to the locking device by positioning the guide wireor catheter in the locking slot of the opening.

It is contemplated that the locking device may be used in conjunctionwith any catheter that receives another device such as a guide wire oranother catheter. For example, it is contemplated that the lockingdevice may be used in conjunction with endoscopes, guide catheters,angioplasty catheters, etc. It is also recognized that when securing aguide wire during a catheter exchange procedure, the first and secondcatheters should be rapid-exchange type catheters to allow access to theguide wire proximate the access port during at least most of thecatheter exchange procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further described with reference to theaccompanying drawings, wherein like numbers refer to like parts inseveral views and wherein:

FIG. 1 is a perspective view of a catheter in accordance with thepresent invention having a U-shaped channel and guide wire lumen fordirecting a guide wire along its shaft and for facilitating rapidcatheter exchange;

FIG. 1A is a cross-sectional view of the catheter of FIG. 1 taken alongthe line 1A-1A;

FIG. 1B is a cross-sectional view of the catheter with guide wire ofFIG. 1 taken along the line 1B-1B;

FIG. 1C is an enlarged fragmentary perspective view of the encircledcatheter section of FIG. 1 at 1C;

FIGS. 2A-2D are cross-sectional views of the catheter of FIG. 1 locatedwithin increasingly larger endoscope channels;

FIG. 3 is a perspective view of an endoscope exchange sheath assembly,without slit, suitable for receiving the catheter of FIG. 1;

FIG. 3A is an enlarged fragmentary perspective view of the encircledsheath section of FIG. 3 at 3A;

FIG. 4 is a perspective view of an alternative embodiment sheathassembly having a slit sheath and two-piece hub, shown in an unlockedposition;

FIG. 4A is a perspective view of the two-piece hub of FIG. 4 in a lockedposition;

FIG. 4B is an enlarged fragmentary perspective view of the encircledsheath section of FIG. 4 at 4B, having a slit;

FIG. 4C is an enlarged fragmentary perspective view of a sheath section,having an overlap, an alternate embodiment of the sheath in FIG. 4B;

FIG. 5 is a perspective view of the catheter of FIG. 1 inserted throughthe endoscope sheath assembly of FIG. 4;

FIG. 6 is a perspective view of a endoscope sheath section containing acatheter having a U-shaped channel containing a guide wire;

FIG. 7 is a partial perspective view of a guide wire within the catheterof FIG. 1 inserted through the endoscope sheath assembly of FIG. 4,which is in turn within an endoscope;

FIG. 7A is a perspective view of the sheath assembly of FIG. 7, havingthe catheter removed;

FIG. 8 is a partial perspective view of an alternative embodiment of asheath assembly, including an introducer;

FIG. 8A is an enlarged perspective view of the introducer of FIG. 8;

FIG. 9A is an enlarged, cross-sectional view of an alternativeembodiment of the introducer of FIG. 8;

FIG. 9B is an enlarged, cross-sectional view of another alternativeembodiment of the introducer of FIG. 8;

FIG. 9C is an enlarged, cross-sectional view of another alternativeembodiment of the introducer of FIG. 8;

FIG. 9D is an enlarged, cross-sectional view of another alternativeembodiment of the introducer of FIG. 8;

FIG. 9E is an enlarged, perspective view of another alternativeembodiment of the introducer of FIG. 8;

FIG. 9F is an enlarged, cross-sectional view of another alternativeembodiment of the introducer of FIG. 8;

FIG. 10 is a perspective view of an illustrative locking device;

FIG. 11 is a partial side view of an illustrative locking devicepositioned on an endoscope having an angled side port;

FIG. 12 is a partial side view detailing the illustrative locking deviceof FIG. 11;

FIG. 13 is a perspective view of another illustrative locking device;

FIG. 14 is a perspective view of yet another illustrative lockingdevice; and

FIG. 15 is a partial side view of another illustrative locking devicepositioned on an endoscope having an angled side port.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a perspective view of a catheter assembly 30 in accordancewith the present invention. Catheter assembly 30 is used in catheterprocedures for accessing targeted anatomical regions through thealimentary canal. The present invention incorporates features whichallow rapid exchange of a catheter by a single operator. The catheter ofthe present invention allows shorter length guide wires to be used,resulting in procedures which require less medical personnel, are lesstime consuming, and less costly. Additionally, the present invention isadaptable to most catheter devices used for catheter procedures withinthe alimentary canal.

Catheter assembly 30 includes a catheter hub assembly 32 and a catheter34, having a guide wire 36 passing through a portion thereof. Catheter34 includes a shaft 38, which in general terms has a proximal end 40, aU-channel 42, a distal tip region 44, a distal end 46 and various lumensdescribed in greater detail below. Catheter hub assembly 32 is operablyconnected to proximal end 40 of shaft 38. Catheter hub assembly 32 ispreferably configured to couple to ancillary devices allowing access toa lumen within shaft 38.

Shaft 38 is a generally tubular shaped member having a generally uniformouter shape at proximal end 40. Shaft 38 may be sized for slidablepassage through the lumen of an endoscope (not shown). Shaft 38 ispreferably formed in an extrusion process. Shaft 38 may be formed of anextruded polymeric material. In one embodiment, the preferred polymericmaterial is polytetrafluoroethylene, polyether block amide, nylon or acombination or blend of these. Catheters which are contemplated include,but are not limited to, cannulas, sphincterotomes, cytology devices, anddevices for stone retrieval and stent placement.

In a preferred embodiment, shaft 38 further includes a distal taper 48which tapers to distal tip region 44. Additionally, tip region 44 mayinclude high contrast, color coded distal markers 50. Finally, distalend 46 may be radiopaque for fluoroscopic visualization of distal tipregion 44 during a catheter procedure.

U-channel 42 of shaft 38 extends between a first, proximal channel end52 and a second, distal channel end 54. U-channel 42 serves to contain,but not necessarily constrain, guide wire 36, between channel proximalend 52 and channel distal end 54. The term “U-channel” refers to achannel shape that allows radial removal of guide wire 36 from thechannel 42, and need not be strictly in the shape of the letter U.Channel 42 in the preferred embodiment is sufficiently large to allowunhindered radial guide wire 36 movement out of channel 42. Further, thechannel walls and radial opening are substantially equal to or slightlylarger than the diameter of a guide wire lumen, described in greaterdetail below. Although it is recognized that proximal channel end 52 maybe located at any location distal of proximal end 40 of shaft 38,channel distal end 54 is preferably located between 10 and 40 cm fromdistal end 46 of catheter shaft 38.

Finally, as shown in FIG. 1A, which is a cross-sectional view of shaft38 taken along line 1A-1A at a location proximal of channel proximal end52, shaft 38 includes ancillary lumen 56, ancillary lumen 58 and guidewire lumen 60.

Ancillary lumen 56 and ancillary lumen 58 extend longitudinally betweenproximal end 40 and distal end 46 of shaft 38. Ancillary lumen 56 andancillary lumen 58 may be injection lumens, allowing for high contrastmedia flow capability for bubble-free opacification and for excellentvisualization of a desired anatomical region. Additionally oralternatively, ancillary lumen 56 and/or ancillary lumen 58 may be usedfor or as part of other ancillary devices, such as a cutting wire lumenor a retrieval balloon lumen.

Guide wire lumen 60 extends longitudinally between proximal end 40 anddistal end 46 of shaft 38 in the preferred embodiment. Further, guidewire lumen 60 is sized to receive guide wire 36. Guide wire lumen 60 maybe a tubular member which is extruded integral catheter shaft 38, oralternatively, guide wire lumen 60 may be a separate tubular memberwhich is coupled to catheter shaft 38. Although in one preferredembodiment the guide wire lumen 60 is a tubular member which is locatedproximate distal end 46 of catheter shaft 38, it is recognized thatguide wire lumen 60 may be formed anywhere along shaft 38, may be anextension of shaft 38 coupled to distal end 46, or guide wire lumen 60may run the entire length of shaft 38.

Referring to FIG. 1B, a cross-sectional view of shaft 38 taken alongline 1B-1B of FIG. 1 is shown. Guide wire 36 may access guide wire lumen60 at a point proximal channel distal end 54. Guide wire 36 extendswithin channel 42 to channel distal end 54, continuing within guide wirelumen 60 through distal tip region 44, and exiting through an opening indistal end 46.

Referring to FIG. 1C, a section of catheter shaft 38 having U-channel 42is shown. The embodiment shown also includes ancillary lumens 56 and 58.Sections of shaft 38 proximate the channel proximal end 52 and distalchannel distal end 54 contain guide wire lumen 60 in communication withU-channel 42. In one embodiment, U-channel 42 has an interior,closed-side geometry, substantially the same as the geometry of guidewire lumen 60. Further, U-channel 42 walls are spaced further than adiameter of guide wire 36 such that guide wire 36 moves freely into andout of U-channel 42.

Catheter shaft 38 can be configured such that U-channel 42 is definedseparately from guide wire lumen 60. With this approach, guide wirelumen 60 is divided into two sections; a first section extending betweenproximal end 40 of shaft 38 and channel proximal end 52; and a secondportion extending between channel distal end 54 and distal end 46 ofshaft 38. Alternatively, the shaft can be configured to define guidewire lumen 60 as extending longitudinally between proximal end 40 anddistal end 46 of shaft 38. In the alternative embodiment, betweenchannel proximal end 52 and channel distal end 54, guide wire lumen 60is integral with U-channel 42. In other words, guide wire lumen 60defines a portion of U-channel 42 such that spacing between outer wallsof U-channel 42 is equal to a diameter of guide wire lumen 60.Regardless of how guide wire lumen 60 and U-channel 42 are defined,U-channel 42 provides for access to guide wire lumen 60 at channeldistal end 54. In this regard, channel distal end 54 can be enlarged tomore easily direct guide wire 36 into guide wire lumen 60.

Guide wire lumen 60 and U-channel 42 allow rapid exchange of catheterassembly 30 when an alternative catheter is necessary during a certainmedical procedure. Shorter length guide wires may be used since guidewire 36 does not pass through shaft proximal end 40 and hub assembly 32,but rather exits the catheter shaft 38 at U-channel 42 locatedsubstantially distal from proximal end 40. The unique catheterconstruction in accordance with the present invention will reducecatheter therapeutic and diagnostic procedure time since catheter deviceexchanges may be performed relatively more easily and quickly by asingle operator. Additional personnel and time associated withmaintaining the placement of a conventional (approximately 400 cm) guidewire within the targeted anatomical region is eliminated, reducing theoverall costs of the procedure.

Referring to FIGS. 2A through 2D, cross-sectional views of endoscopeworking channels 70-76 containing a catheter according to FIG. 1 areshown. In the examples illustrated in FIGS. 2A through 2D, workingchannel inside diameters 70, 72, 74, and 76 are 2.8, 3.2, 3.8, and 4.2mm, respectively. FIG. 2A illustrates catheter shaft 38 having ancillarylumens 54 and 56, U-channel 42, and guide wire 36 within U-channel 42.Further, shaft 38 is shown within a first size endoscope working channel70. In FIG. 2A, guide wire 36 is effectively radially constrained bysmall sized working channel 70 that closely surrounds U-channel 42.

FIG. 2B illustrates catheter containment within a second size workingchannel 72, slightly larger than the working channel 70 of FIG. 2A. InFIG. 2B, guide wire 36 is able to move out of U-channel 42 to a positiondenoted with dashed lines at 80. FIG. 2C shows shaft 38 contained withina third, even larger sized working channel 74. Guide wire 36 is able tomove completely out of U-channel 42 to position 82 shown with dashedlines. Finally, FIG. 2D demonstrates catheter shaft 38 within a fourthsize working channel 76. In this even larger working channel, guide wire36 lies within an even larger cross-sectional area, and is able to moveto a position shown in FIG. 2D with dashed lines at 84.

As shown with the larger endoscope working channels (FIGS. 2C and 2D),the potential for guide wire 36 to slip out of U-channel 42 creates apotential for the guide wire 36 to become pinched and restrict desiredmovements of both guide wire 36 and catheter shaft 38. For this reason,when larger endoscope working channels are used, an exchange sheathhaving a sufficiently small inner diameter so as to constrain guide wiremovement to within the catheter U-channel 42 is employed with thepreferred embodiment. Generally speaking, an endoscope exchange sheathin accordance with the preferred embodiment allows for use of a radiallyaccessible guide wire, which is longitudinally aligned with thecatheter, while presenting a circular profile to an endoscope andmitigating guide wire pinching problems between the catheter and theendoscope working channel wall.

Referring to FIG. 3, an endoscope exchange sheath assembly 100 havingsheath hub assembly 102 and a sheath 104 is shown. The sheath 104includes a lumen 106 and a distal end 108. FIG. 3A shows a section ofsheath 104, having lumen 106 for receiving a catheter. Basically, withreference to FIG. 1, catheter 34 is fed through lumen 106 of sheath 104such that sheath 104 encompasses guide wire 36 within U-channel 42.Sheath 104 is adapted to be disposed within an endoscope workingchannel, thereby providing a smaller diameter channel than that of thesurrounding endoscope working channel constraining the guide wire 34(FIG. 1) to the U-channel 50 (FIG. 1), and mitigating the potentialproblems shown in FIGS. 2C and 2D.

Referring to FIG. 4, an alternate endoscope exchange sheath assembly 110is shown. Sheath assembly 110 includes a two-piece hub assembly 112 anda sheath 114 defining lumen 116 and having slit 118 extendinglongitudinally over its length, terminating at distal end 120. Slit 118in sheath 114 is shown in more detail in FIG. 4B.

Referring again to FIG. 4, two-piece hub assembly 112 has a proximal hubportion 122 and a distal hub portion 124, having a proximal slit 126 anda distal slit 128, respectively. Sheath slit 118 is in communicationwith hub slits 126 and 128, allowing a guide wire (not shown) to beradially slid into or out of sheath assembly 110. Proximal hub portion122 is shown unlocked (position “A”) in FIG. 4, aligning hub proximalslit 126 with hub distal slit 128 and sheath slit 118, providing acontinuous slit for guide wire radial movement into and out of thesheath assembly 110. Proximal hub portion 122 is shown locked, inposition “B”, in FIG. 4A, whereby proximal hub slit 126 is rotated withrespect to distal hub slit 128, preventing a guide wire (not shown)within hub assembly 112 from being moved radially out of hub assembly112. Proximal hub portion 122 is set to position B (FIG. 4A) when radialguide wire movement is not desired.

FIG. 4C illustrates a portion of an alternate embodiment sheath 130having a lumen 132, a sheath wall opening 134 and sheath wall overlap136. A guide wire (not shown) is able to be slid out of lumen 132 ofsheath 130 by maneuvering the guide wire into sheath wall opening 134and through overlap 136.

Referring to FIG. 5, catheter assembly 30 depicted in FIG. 1 is showninserted within endoscope exchange sheath assembly 110 depicted in FIG.4. More particularly, catheter 34 is inserted through slitted sheathassembly 110, extending distally out sheath distal end 120. Guide wire36 (shown partially in FIG. 5) is positioned within U-channel 42 ofcatheter 34, along guide wire lumen 60 (FIG. 1B), and extends from shaftdistal end 46. Further, guide wire 36 is engaged by hub assembly 112.More particularly, guide wire 36 passes within and is engaged byproximal slit 126 and distal slit 128 of hub assembly 112. Sheathproximal hub portion 122, having proximal slit 126, is shown in lockedposition relative to sheath distal hub portion 124, having distal slit128. Thus, in the locked position, hub assembly 112 of sheath assembly110 prevents radial withdrawal of guide wire 36, otherwise inserted inU-channel 42 of catheter 34, from distal the channel proximal end 52.

Referring to FIG. 6, a section of FIG. 5 is shown in detail, havingendoscope sheath 114 containing catheter shaft 38, which furthermaintains guide wire 36 within U-channel 42. As shown, sheath 114 isable to constrain movement of guide wire 36 from U-channel 42 whensheath 114 is within a larger endoscope working channel, for example asillustrated in FIGS. 2C and 2D. Importantly, the sheath 114 embodimentillustrated in FIG. 6 includes longitudinal slit 118, allowing guidewire 36 to be peeled from catheter shaft 38 and endoscope sheath 114. Inother words, as previously described, U-channel 42 is sized larger thanguide wire 36 such that guide wire 36 can displace radially fromU-channel 42. Sheath 114 prevents undesired displacement of guide wire36 from U-channel 42 under normal operating conditions. However, ifadequate radial force is placed on guide wire 36 by an operator, guidewire 36 will separate sheath 114 along slit 118 such that guide wire 36is displaced from sheath 114 and U-channel 42. Referring to FIG. 7,guide wire 36 is shown inserted within catheter assembly 30 of FIG. 1,which is inserted through endoscope sheath assembly 110 of FIG. 4, whichis in turn within an endoscope 150. Sheath assembly 110 includes sheath114 that has slit 118 and two-piece hub assembly 112, shown at a lockedposition “B” (also in FIG. 4A). Having hub assembly 112 locked preventsguide wire 36 from moving radially out of sheath 114 through slit 118.Guide wire 36 can be restrained from longitudinal movement by applyingfinger pressure on the guide wire 36 against hub assembly 112.

Referring to FIG. 7A, endoscope 150 and sheath assembly 110 of FIG. 7are shown without the catheter assembly 30 inserted, as after catheterwithdrawal. Sheath hub assembly 112 is shown in unlocked position at “A”(also in FIG. 4). Having hub assembly 112 unlocked allows radialmovement of guide wire 36 out of sheath 114 through slit 118, but suchmovement may be restrained by trapping guide wire 36 against the outsideof sheath 114 using one finger, providing ease of guide wire 36 controlduring catheter exchanges.

In one possible endoscopic procedure, an endoscope 150, as illustratedin FIG. 7, is first introduced into the mouth of a patient and is guidedthrough the patient's alimentary canal. Specifically, endoscope 150 isguided down the esophagus, through the stomach, past the pyloricsphincter of the stomach and into the duodenum. Endoscope 150 has alumen extending longitudinally between its proximal end and the distalend. Endoscope 150 is guided through the alimentary canal until a distalend (not shown) of endoscope 150 is proximate the target area within theanatomy to receive treatment. In an endoscopic biliary procedure,endoscope 150 is guided into the duodenum until the opening at thedistal end of the endoscope 150 is proximate the papilla of vater. Thepapilla of vater is located between the sphincter of oddi, which leadsto the common bile duct, hepatic, and pancreatic ducts. The proximal end(shown in FIGS. 7 and 7A) of endoscope 150 extends and remains outsidethe mouth of the patient.

With endoscope 150 properly positioned within the patient, catheterassembly 30 is prepared for insertion into the endoscope. First, guidewire 36 is fed into the guide wire lumen 60 (FIGS. 1A-1C) of shaft 38.More particularly, a distal end of guide wire 36 is placed withinU-channel 42, distal the channel proximal end 52. The guide wire 36 isthen fed to channel distal end 54 (FIG. 1) into guide wire lumen 60.Finally, guide wire 36 is fed through shaft 38 to distal tip region 40(FIG. 1). In one method, catheter 32 is then inserted directly intoendoscope 150 working channel. This method may be practiced with anendoscope having a sufficiently small working channel inside diameter,as illustrated in FIG. 2A, to constrain guide wire 36 movement without asheath.

However, in a preferred method (with reference to FIG. 7), catheterassembly 30, threaded with guide wire 36, is inserted into sheathassembly 110, thereby constraining guide wire 36 from slipping radiallyout of U-channel 42. More particularly, catheter 34 is inserted intoendoscope 150 working channel, but leaving channel proximal end 52proximate sheath hub assembly 112, and leaving a portion of guide wire36 extending from the channel proximal end 52 as well. Notably, sheathhub assembly 112 includes hub slits 126 and 128 which receive a portionof guide wire 36. Thus, in the preferred embodiment, hub assembly 112 islocked, preventing unwanted radial guide wire 36 movement. In apreferred method, the loading of guide wire 34 into catheter shaft 38and catheter shaft 38 into sheath assembly 110 is done prior toinserting endoscope 150 into a patient (not shown).

Endoscope sheath 114, containing catheter shaft 38, is inserted intoendoscope 150 working channel. Endoscope sheath 114 serves to constrainradial guide wire 36 movement over the approximate length of U-channel42. Catheter shaft 38 and sheath 114 are inserted together intoendoscope 150 until both are near a distal end (not shown) of endoscope150. Catheter shaft 38 and sheath 114 may be, either or both, advanceduntil exiting the distal end of endoscope 150.

In one method, guide wire 36 is advanced until guide wire 36 distal tipis positioned within the target area in the biliary tree (including thecommon bile, hepatic or pancreatic ducts). For example, the distal tipof guide wire 36 may be guided through the orifice leading to thepapilla of vater for access to the biliary tree. Catheter shaft 38 maythen be advanced over guide wire 36, tracking catheter assembly 30,until catheter distal tip region 40 (FIG. 1) exits distal end ofendoscope 150 and is positioned within the desired duct. In anothermethod, guide wire 36 and catheter assembly 30 are advanced togetheruntil catheter distal end 42 (FIG. 1) is positioned at the target area.It is also recognized that the catheter could be first advanced to nearthe target area, followed by inserting the guide wire when needed toadvance the catheter further.

Once guide wire 36 is in position at the target area, catheterprocedures, including injecting contrast media, such as radiopaque dye,through ancillary lumens 56 or 58 (FIG. 1A-1C) into the common bile ductfor visualization of the duct, can be performed. After the desiredcatheter procedure has been completed, catheter assembly 30 can beexchanged or removed from endoscope 150, leaving guide wire 36 inposition for other catheter procedures. Catheter assembly 30 and sheathassembly 110 may also be removed together.

One method of withdrawing catheter 34 from endoscope 150 is possibleusing either a slitted/overlapped endoscope sheath 114 as depicted inFIGS. 4 through 4C, or a sheath 104 without a slit as depicted in FIGS.3 through 3A. Using this method, best visualized with reference to FIG.7, guide wire 36 is held to prevent longitudinal movement while catheter34 is retracted within endoscope sheath 114 (or 104). Catheter 34retraction leaving the guide wire 36 in position within the patient isenabled by U-channel 42 being radially open to guide wire 36 removal incatheter shaft 36. Once catheter retraction has brought channel distalend 54 (FIG. 1) to a point proximate sheath hub assembly 112, only arelatively short portion of guide wire 36, from channel distal end 54 todistal end 46 (FIG. 1) of catheter shaft 38, remains within catheter 34.A single operator can remove this remaining portion of guide wire 36from catheter 34 by first slightly retracting catheter assembly 30(while still holding guide wire 34 in place) out of sheath assembly 110(or 100), such that a portion of guide wire 36 is accessible distal ofcatheter distal end 46. In other words, a small portion of guide wire 36is accessible between distal end 46 of catheter 34 and distal hubportion 124 of sheath assembly 110. The accessible portion of guide wire36 is then held by the operator, while withdrawing the remaining portionof catheter 34 completely over guide wire 36. In an alternative method,the distal end of the endoscope can include an elevator which could beutilized to lock the distal end of the guide wire in position while thecatheter is removed.

Exchange of endoscope sheath assembly 110 may be desired, as when astent (not shown) is to be advanced over guide wire 36, and the stenthas a larger outside diameter than can be accommodated by the sheath114. One method of exchanging an endoscope sheath assembly 110 may beused where sheath 114 is slitted as in FIG. 4B, or overlapped, as insheath 130 in FIG. 4C. Referring to FIG. 7A, two-piece hub assembly 112is turned to the unlocked position “A” (also shown in FIG. 4). Guidewire 36 is pulled radially away from sheath hub assembly 112 and throughslit 118 in sheath 114. Guide wire 36 is then held, preferably againstsome portion of endoscope 150, to prevent guide wire 36 from beingdislodged from position within the patient. Sheath 114 is retracted fromendoscope 150, guide wire 36 being “peeled” away from sheath 114. Sheathretraction is continued until sheath 114 is completely outside ofendoscope 150 and over guide wire 36. At this point, guide wire 36 iswithin endoscope 150 working channel, and stents, catheters, andendoscope sheaths may be advanced over guide wire 36.

Another method of exchanging both endoscope sheath assembly 110 andcatheter assembly 30 may be used where the sheath 114 is slitted as inFIG. 4B, or overlapped, as in sheath 130 in FIG. 4C. Referring to FIG. 7and 7A, two-piece hub assembly 112 is turned to the unlocked position“A” (FIG. 7A). Guide wire 36 is pulled radially away from U-channel 42of catheter 34, from hub assembly 112 and through slit 118 in sheath114. Guide wire 36 is then held, preferably against some portion ofendoscope 150, to prevent guide wire 36 from being dislodged fromposition within the patient. Sheath 114 and catheter 34 are retractedfrom endoscope 150, with guide wire 36 being “peeled” away from sheath114. Sheath assembly 110 and catheter assembly 30 retraction arecontinued until sheath 114 and catheter 34 are completely outside ofendoscope 150 and over guide wire 36. At this point, guide wire 36remains in a position within endoscope 150 and patient. A singleoperator can access a small portion of guide wire 36 between distal end46 (FIG. 1) of catheter 34 to hold guide wire 36 in place while catheterassembly 30 is completely removed or disengaged from guide wire 36.

While sheath assembly 110 has been described as including a two-piecehub assembly 112 in conjunction with sheath 114, other assemblies may beused. For example, referring to FIG. 8, an alternate sheath assembly 160is shown. Sheath assembly 160 includes an introducer 162, an attachmentmeans 164 and a sheath 166. Similar to previous embodiments, sheath 166defines a lumen (not shown) and includes a slit 168 extendinglongitudinally over its length, terminating at a distal end 170. Sheath166 is generally identical to sheath 104 and sheath 114 previouslydescribed. Introducer 162 is attached to sheath 166 by attachment means164 such that lumen (not shown) of sheath 166 is in fluid communicationwith an interior portion of introducer 162. In one preferred embodiment,attachment means 164 is a flexible membrane which seals sheath 166 tointroducer 162. Alternatively, other forms of attachment, such as anadhesive or frictional engagement between introducer 162 and sheath 166may also be useful.

Referring to FIG. 8A, introducer 162 is shown in greater detail.Introducer 162 is a funnel-shaped device including a horn 172 and a neck174. In one preferred embodiment, horn 172 and neck 174 are integrallyformed as a singular body.

Horn 172 is preferably a conically-shaped body having an outer wall 176.Outer wall 176 defines an interior space and includes a guidewire-receiving notch 180 formed near proximal end 182 of horn 172. Guidewire-receiving notch 180 is preferably J-shaped and includes an entryend 184 and a locking end 186. As shown in FIG. 8A, entry end 184 isopen at proximal end 182 of horn 172. Conversely, locking end 186 isclosed.

Neck 174 is preferably tubular in shape, and includes a passage 188.Passage 188 is configured to be in fluid communication with interiorspace of horn 172. In the preferred embodiment, horn 172 and neck 174are formed of a plastic material. Alternatively, any other semi-rigid orrigid, surgically-safe material may be used.

Referring to FIGS. 1, 8 and 8A, during use, catheter assembly 34(FIG. 1) is inserted within sheath assembly 160. More particularly,distal end 46 (FIG. 1) of catheter shaft 38 (FIG. 1), including guidewire 36 (FIG. 1) is placed within horn 172 of introducer 162. Theconical shape of horn 172 assists in directing distal end 46 of cathetershaft 38, including guide wire 36, into passage 188 of neck 174.Catheter shaft 38 continues forward within lumen (not shown) of sheath166 until distal end 46 of catheter shaft 38 extends from distal end 170of sheath 166.

Once properly inserted within sheath assembly 160, a proximal end ofguide wire 36 (FIG. 1) is maintained within guide wire-receiving notch180. More particularly, a portion of guide wire 36 is forced by anoperator through entry end 184 of guide wire-receiving notch 180 andforced within locking end 186 thereof. In this regard, locking end 186preferably has a diameter slightly smaller than that of guide wire 36.Thus, locking end 186 frictionally maintains guide wire 36. Conversely,guide wire 36 can easily be released from guide wire-receiving notch 180by sliding guide wire 36 from locking end 186 and out of entry end 184.Thus, sheath assembly 160 functions in a manner highly similar to sheathassembly 100 and sheath assembly 110 previously described.

Referring to FIG. 9A, an alternative embodiment of an introducer 190 isshown. Introducer 190 includes a horn 192, a neck 194 and a valve 196.Similar to previous embodiment, horn 192 and neck 194 are preferablyintegrally formed as a singular body. Horn 192 includes an outer wall197 which defines a guide wire-receiving notch 198 and valve-receivingslots 200. Valve 196 includes a valve body 202 sized to fit within outerwall 197 of horn 192. Further, valve 196 includes ribs 204 extendingfrom valve body 202. Ribs 204 are preferably sized to mate withinvalve-receiving slots 200 of horn 192. Thus, valve 196 is maintainedwithin horn 192 via interaction of ribs 204 with valve-receiving slots200. In this regard, valve-receiving slots 200 are preferably positionedalong horn 192 proximal neck 194. Valve 196 is preferably made of arubber-type material.

During use, introducer 190 finctions in a manner highly similar tointroducer 162 (FIGS. 8 and 8A) previously described. Additionally,however, valve 196 forms a seal about catheter shaft 38 (FIG. 1). Thus,upon insertion into a human body, valve 196 prevents bodily fluids, suchas bile, from backing up through the sheath assembly. Additionally,valve 196 can provide for aspiration, if desired.

Referring to FIG. 9B, an alternative embodiment of an introducer 206 isshown. Introducer 206 is highly similar to introducer 190 (FIG. 9A)previously described. In this regard, introducer 206 includes a horn208, a neck 210 and a valve 212. Horn 208 is preferably integrallyformed with neck 210 and includes an outer wall 214 defining a guidewire-receiving notch 216 and valve-receiving slots 218. Similar to valve196 (FIG. 9A), valve 212 includes a valve body 220 and ribs 222. Ribs222 are sized to mate within valve-receiving slots 218 of horn 208. Inthis regard, valve-receiving slots 218 are positioned proximate aproximal end 224 of horn 208. Introducer 206, including valve 212,functions in a manner highly similar to introducer 190 (FIG. 9A) aspreviously described.

It is recognized that the fluid blocking function provided by valve 212can be achieved with other designs. For example, referring to FIG. 9C,an alternative embodiment of an introducer 226 is shown. Introducer 226includes a horn 228, a neck 230 and an O-ring 232. Horn 228 and neck 230are preferably formed as an integral body. Horn 228 preferably includesa guide wire-receiving notch (not shown) similar to that previouslydescribed and an interior slot 234. Interior slot 234 is preferablypositioned proximate neck 230 and is sized to maintain O-ring 232.Alternatively, interior slot 234 can be formed in neck 230. O-ring 232is preferably made of a rubber-type material. Further, O-ring 232 has aninner diameter slightly smaller than that of horn 228 and neck 230.Thus, during use, O-ring 232 forms a seal about catheter shaft 38 (FIG.1), blocking passage of bodily fluids, such as bile, into horn 228.

Referring to FIG. 9D, another alternative embodiment of an introducer236 is shown. Introducer 236 is similar to a touhey-borst system andincludes an upper horn section 238, a lower horn section 240 and agrommet 242. Upper horn section 238 includes an outer wall 244 defininga proximal end 246, a grommet-receiving flange 248 and a distal end 250.Proximal end 246 of horn section 238 preferably includes a guidewire-receiving notch (not shown) similar to that previously described.Distal end 250 is threaded and includes a passage 252 sized to receive aportion of lower horn section 240.

Lower horn section 240 includes a body 254 defining a proximal end 256,an intermediate portion 258 and a distal end 260. An interior passage266 is configured to communicate with passage 252 and extends fromproximal end 256 to distal end 260. Finally, proximal end 256 includes athreaded slot 262 sized to threadably receive distal end 250 of upperhorn section 238.

Grommet 242 is preferably made of a rubber-type material and is sized tonest within grommet-receiving flange 248 of upper horn section 238 whileabutting proximal end 256 of lower horn section 240.

Introducer 236 is assembled by placing grommet 242 withingrommet-receiving flange 248 of upper horn section 238. Distal end 250of upper horn section 238 is then threadably secured to proximal end 258of lower horn section 240. As upper horn section 238 is threadablysecured to lower horn section 240, proximal end 256 of lower hornsection 240 compresses grommet 242 within grommet-receiving flange 248of upper horn section 238. During use, introducer 236 functions in amanner highly similar to that previously described. In this regard,grommet 242 forms a seal about catheter shaft 38 (FIG. 1). Further,aspiration can be achieved, if desired, by loosening lower horn section240 relative to upper horn section 238.

Referring to FIG. 9E, yet another alternative embodiment of anintroducer 266 is shown. Introducer 266 includes a horn 268, a neck 270and a valve 272. Preferably, horn 268, neck 270 and valve 272 areintegrally formed as a singular body. In this regard, valve 272 isformed while molding horn 268 and neck 270 by imparting a controlledflash at distal end 274 of neck 270.

Introducer 266 performs in a manner highly similar to that previouslydescribed. Thus, valve 272 forms a seal about catheter shaft 38 (FIG.1), thereby preventing back flow of bodily fluids, such as bile, intohorn 268.

Referring to FIG. 9F, another alternative embodiment of an introducer276 is shown. Introducer 276 includes a horn 278, a neck 280 and a valve282. Horn 278 and neck 280 are preferably integrally formed as asingular body. In this regard, horn 278 and neck 280 are defined by anouter wall 284. Outer wall 284 forms a guide wire-receiving notch 286and an exterior slot 288. Guide wire-receiving notch 286 is similar tothat previously described. Exterior slot 288 is positioned along neck280 and is sized to maintain a portion of valve 282. Alternatively,exterior slot 288 can be positioned along horn 278.

Valve 282 is preferably a rubber-type sock defined by an upper rib 290,a side wall 292 and a shoulder 294. Upper rib 290 is preferably sized tomount within exterior slot 288 of neck 280. Side wall 292 is preferablyflexible so as to stretch along neck 280. Finally, shoulder 294 ispreferably configured to abut a distal end 298 of neck 280. With thisconfiguration, valve 282 is placed over distal end 298 of neck 280 suchthat shoulder 294 contacts distal end 298. Due to the preferred flexiblecharacteristic of valve 282, side wall 292 is stretched until upper rib290 nests within exterior slot 288 of neck 280.

During use, the catheter shaft 38 (FIG. 1) is placed through introducer276 such that shoulder 294 of valve 282 forms a seal about cathetershaft 38. Thus, valve 282 prevents undesired back flow of bodily fluids,such as bile.

FIG. 10 is a perspective view of an illustrative locking device for usewith an endoscope having a side instrument port. The illustrativelocking device is generally shown at 320 and includes a body member 322.At one end, the body member 322 includes one or more hook members 324for attaching the locking device to a shaft of an endoscope or the like(see FIG. 11). At the other end, the body member 322 includes a securingmechanism for securing a guide wire or catheter to the locking device.

The hook members 324 may be provided in pairs, as shown in FIG. 10, oroffset from one another, as shown in FIG. 13. In either case, the hookmembers 324 are adapted to clip and secure the locking device to theshaft of an endoscope or the like.

The securing mechanism preferably includes one or more openings providedin the body member 322. In the embodiment shown, the body member 322includes a guide wire opening 326 and a catheter opening 332. The guidewire opening 326 is similar to the guide wire-receiving notch 180 ofFIG. 8A. The guide wire opening 326 is preferably J-shaped, andpreferably includes an entry slot 328 and a locking slot 330. Thecatheter opening 332 is boot shaped, and also preferably includes anentry slot 334 and a locking slot 336.

The entry slot 328 of the guide wire opening 326 is dimensioned to belarger than the diameter of a guide wire. The locking slot 330 of theguide wire opening 326 is dimensioned to be somewhat smaller than thediameter of a guide wire. Accordingly, a guide wire can be secured tothe body member 322 by inserting a portion of the guide wire through theentry slot 328 of the guide wire opening 326 and into the locking slot330. The locking slot 330 frictionally secures the guide wire relativeto the body member 322.

Likewise, the entry slot 334 of the catheter opening 332 is dimensionedto be larger than the diameter of a catheter. The locking slot 336 ofthe catheter opening 332 is dimensioned to be somewhat smaller than thediameter of a catheter. Accordingly, a catheter can be secured to thebody member 322 by inserting a portion of the catheter through the entryend 334 of the catheter opening 332 and into the locking slot 336. Thelocking slot 336 frictionally secures the catheter relative to the bodymember 322.

FIG. 11 is a partial side view of an illustrative locking devicepositioned on an endoscope with an angled side port extending therefrom.The endoscope is generally shown at 350, and includes a main shaft 352with a lumen extending therethrough. A side port 356 extends laterallyaway from the main shaft 352 at an angle. The side port 356 providesaccess to the lumen of the main shaft 352. Accordingly, a guide wireand/or catheter may access the lumen of the main shaft 352 via the sideport 356.

The side port 356 preferably includes a side port opening 354 which islaterally spaced from the main shaft 352 due to the angular displacementbetween the main shaft 352 and the side port 356. The side port opening354 is in fluid communication with the lumen of the main shaft 352 via aconnection tube 355. The connection tube 355 intersects a side wall ofthe main shaft 352 at an angle, as shown.

A locking device having a body member 360 is shown clipped onto the mainshaft 352 of the endoscope. The body member 360 includes a number ofhook members 358 for attaching the locking device to the main shaft 352.Two hook members are visible in FIG. 11. The hook members 358 aresimilar to the hook members 324 described above with respect to FIG. 10.

The body member 360 extends away from the hook members 358 and generallyparallel to the side port 356. In FIG. 11, the body member is obscuredby the main shaft 352 and side port 356. The body member 360 extendsupward past the side port opening 354, wherein a securing mechanism isprovided. Preferably, the securing mechanism is a J-shaped guide wireopening 362.

In use, a guide wire is advanced into the body via the endoscope. Duringthe advancement of the guide wire, the proximal end thereof may be movedto a first position 364, which is in the entry slot of the guide wireopening 362. Once the guide wire is in a desired position within thebody, the guide wire may be moved to a second position 366, which is inthe locking slot of the guide wire opening 362. The locking slot of theguide wire opening 362 frictionally secures the guide wire relative tothe body member 360.

FIG. 12 is a partial side view detailing the illustrative locking deviceof FIG. 11, with an additional oversized catheter opening shown. Theside port of the endoscope is shown at 356, and the body member of thelocking device is shown at 360. Positioned proximate the side portopening 354 is a guide wire opening 362 and an oversized catheteropening 370. Like above, the guide wire opening is J-shaped and includesan entry slot and a locking slot. Thus, the guide wire may be moved tothe first position 364, which is in the entry slot of the guide wireopening 362. Once the guide wire is in a desired position within thebody, the guide wire may be moved to the second position 366, which isin the locking slot of the guide wire opening 362. The locking slot ofthe guide wire opening 362 frictionally secures the guide wire relativeto the body member 360.

The oversized catheter opening 370 is sized to restrict lateral movementof the catheter 372 but not longitudinal movement of the catheter 372.Providing a guide wire opening that can secure the guide wire relativeto the body member, and an oversized catheter opening for onlyrestricting lateral movement of the catheter 372 may be particularlyuseful in performing a catheter exchange procedure. For example, duringa catheter exchange procedure, the guide wire opening may maintain theposition of the guide wire. The oversized catheter opening 370 mayseparate the catheter from the guide wire, as the catheter is withdrawn.The first and second catheters should be single-operator exchange typecatheters to provide access to the guide wire during the exchange.

FIG. 13 is a perspective view of another illustrative locking device.The embodiment shown in FIG. 13 is similar to the embodiment shown inFIG. 10, but the hook members are laterally offset rather than aligned.For example, hook member 380 is laterally offset from hook member 382 bya distance “D”. This configuration is another example of an attachmentmechanism for attaching the body member to a catheter shaft.

FIG. 14 is a perspective view of yet another illustrative lockingdevice. The locking device is generally shown at 400, and includes abody member 401 having an attachment mechanism 402 at one end and asecuring mechanism 404 at the other. The attachment mechanism 402includes a first hook member 406 and a second hook member 408. The firsthook member 406 and the second hook member 408 are adapted to extendaround a substantial portion of the shaft of an endoscope or the like.Thus, the first hook member 406 and the second hook member 408 may clipthe body member 401 to the desired shaft.

The securing mechanism 404 includes a J-shaped guide wire opening 410and a flap-type catheter opening 412. The J-shaped guide wire opening410 operates similar to that described above. The flap-type catheteropening 412 has a flap 414 formed by cutting the catheter opening 412from the body member 401. The flap 414 is preferably curved to form achannel 416, wherein the end portion 418 of the channel 416 loops backto near the surface of the body member 401. In this configuration, acatheter or guide wire may be selectively provided in the channel 416,which may bend the flap away from the body member 401. Accordingly, theflap 412 may provide force between the guide wire or catheter and thebody member 401 to effectively secured the guide wire or catheter to thebody member 401.

FIG. 15 is a partial side view of yet another illustrative lockingdevice 500. The locking device 500 is positioned between the side port504 and the main shaft 506 of the endoscope 502. The locking deviceincludes a body member 510 that is attached to the main shaft 506 usinga strap 512. Preferably, the strap 512 extends around the entirecircumference of the main shaft 506. Further, the body member 510 mayinclude a guide wire opening 514 and one or more catheter openings 516,as shown.

It will be understood that this disclosure, in many respects, is onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, material, and arrangement of parts without exceeding thescope of the invention. Accordingly, the scope of the invention is asdefined in the language of the appended claims.

1. A locking device for use in combination with an endoscope and firstand second elongate medical devices insertable therein, the lockingdevice comprising: a body member having a proximal portion and a distalportion; an attaching member for attaching the body member to theendoscope, the attaching member connected to the distal portion of thebody member; a first securing member for securing the first elongatemedical device, the first securing member connected to the proximalportion of the body member; and a second securing member for securingthe second elongate medical device, the second securing member connectedto the proximal portion of the body member.
 2. A locking device as inclaim 1, wherein the attaching member is adapted to allow releasableattachment of the body member to the endoscope.
 3. A locking device asin claim 1, wherein the first and second securing members are adapted toallow releasable securing of the first and second elongate medicaldevices.
 4. A locking device as in claim 3, wherein the first elongatemedical device comprises a guidewire.
 5. A locking device as in claim 4,wherein the second elongate medical device comprises a catheter.
 6. Alocking device as in claim 4, wherein the first securing member isconfigured to frictionally secure the guidewire relative to the bodymember.
 7. A locking device as in claim 5, wherein the second securingmember is configured to restrict lateral but not longitudinal movementof the catheter.
 8. A locking device as in claim 6, wherein the firstsecuring member is J-shaped and includes an entry slot and a lockingslot.
 9. A locking device as in claim 8, wherein the guidewire is freelymoveable when in the entry slot and the guidewire is frictionallysecured when in the locking slot.
 10. A locking device as in claim 8,wherein the entry slot is a slot in a proximal end of the body member.11. A locking device as in claim 7, wherein the second securing memberis an opening in a lateral side of the body member.
 12. A locking deviceas in claim 11, wherein the second securing member is T-shaped.
 13. Alocking device for use in combination with an endoscope and a guidewireand catheter insertable in the endoscope, the locking device comprising:a body member; an attaching member for attaching the body member to theendoscope; a securing member for releasably frictionally securing theguidewire; and a restricting member for restricting lateral but notlongitudinal movement of the catheter.
 14. A locking device as in claim13, wherein the locking device is configured for use with an endoscopehaving a proximal port, and the attaching member is sized and configuredto allow releasable attachment to the endoscope distal of the proximalport.
 15. A locking device as in claim 14, wherein the body member isconfigured such that when the attaching member is attached to theendoscope, distal of the proximal port, the securing member and therestricting member are disposed proximal of the proximal port.
 16. Alocking device as in claim 15, wherein the securing member includes anentry slot and a locking slot, wherein the guidewire is freely moveablewhen in the entry slot and the guidewire is frictionally securedrelative to the body member when in the locking slot.
 17. A lockingdevice as in claim 16, wherein the securing member is a J-shaped openingin a proximal end of the body member.
 18. A locking device as in claim15, wherein the restricting member is an opening in a lateral side ofthe body member.
 19. A locking device as in claim 18, wherein theopening is T-shaped and is sized to restrict lateral but notlongitudinal movement of the catheter with respect to the body member.20. A locking device for use in combination with an endoscope and aguidewire and elongate medical device insertable in the endoscope, thelocking device comprising: a body member; an attaching member forattaching the body member to the endoscope; a first securing member forreleasably securing the guidewire; and a second securing member forreleasably securing the elongate medical device.
 21. A locking device asin claim 20, wherein the first securing member is configured to allowreleasable frictional securing of the guidewire to the body member. 22.A locking device as in claim 21, wherein the first securing memberincludes an entry slot and a locking slot, wherein the guidewire isfreely moveable when in the entry slot and the guidewire is frictionallysecured relative to the body member when in the locking slot.
 23. Alocking device as in claim 21, wherein the first securing member is aJ-shaped opening in the body member.
 24. A locking device as in claim20, wherein the second securing member includes a flap curved to form achannel, wherein the flap is configured such that it bends away from thebody member when the elongate medical device is disposed in the channel,the flap providing a force on the elongate medical device to secure theelongate medical device to the body member.
 25. A locking device as inclaim 24, wherein the elongate medical device is a catheter and the flapand channel are sized to provide a force to secure the catheter to thebody member.
 26. A locking device as in claim 24, wherein the elongatemedical device is a guidewire, and the flap and channel are sized toprovide a force to secure the guidewire to the body member.
 27. Alocking device as in claim 24, wherein the flap is cut from the bodymember, wherein a first, attached portion of the flap is bent away fromthe body member and a second, free portion of the flap is curved towardsthe body member to form the channel.
 28. A medical system comprising: anendoscope; and a locking device for reversibly securing first and secondelongate medical devices adapted to be inserted into the endoscope, thelocking device adapted to be attached to the endoscope, the lockingdevice having a body member having a proximal portion and a distalportion; an attaching member for attaching the body member to theendoscope, the attaching member connected to the distal portion of thebody member; a first securing member for releasably securing the firstelongate medical device relative to the body member, the first securingmember connected to the proximal portion of the body member; and asecond securing member for releasably securing the second elongatemedical device relative to the body member, the second securing memberconnected to the proximal portion of the body member.
 29. A medicalsystem as in claim 28, wherein the first elongate medical device is aguidewire and the first securing member releasably frictionally securesthe guidewire relative to the body member.
 30. A medical system as inclaim 28, wherein the second elongate medical device is a catheter andthe second securing member releasably restricts lateral but notlongitudinal movement of the catheter relative to the body member.
 31. Amedical system as in claim 29, wherein the first securing memberincludes an entry slot and a locking slot, wherein the guidewire isfreely moveable when in the entry slot and the guidewire is frictionallysecured relative to the body member when in the locking slot.
 32. Amedical system as in claim 31, wherein the first securing member is aJ-shaped opening in a proximal end of the body member.
 33. A medicalsystem as in claim 30, wherein the second securing member is an openingin a lateral side of the body member.